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Australia TGA: eCTD Specification and guidance for use - AU module 1 and regional information v3.2
The Therapeutic Goods Administration (TGA) has updated its eCTD AU Module 1 and Regional Information v3.2 guidance. A 4 September 2026 update introduced minor editorial changes and added links to the TGA page Dossier requirements for non-prescription medicines and the new user guide Submitting data in electronic Common Technical Document (eCTD) format for a non-prescription medicine application. Dossier requirements for non-prescription medicines: Submitting data in eCTD form

Sharan Murugan
58 minutes ago3 min read
